Data and Safety Monitoring
Section 10
Additional Resources
Contributors
Contributing Editor
Gina Uhlenbrauck
Resource | Description |
---|---|
Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH, and Susan Ellenberg, PhD) | December 8, 2017, PCT Grand Rounds presentation, available as a webinar, slide set, and podcast. |
Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical Trials: A Practical Perspective. Volume 6. Wiley (Second edition scheduled 2019) |
Provides a practical overview of data monitoring in clinical trials, including the purpose, responsibilities, and operation of DMCs. Useful for those managing and conducting clinical trials and those serving on DMCs or regulatory and ethical committees. |
DeMets DL, Furberg CD, Friedman LM. Data Monitoring in Clinical Trials: A Case Studies Approach. Springer; 2006. |
A collection of cases are used to explore issues in data monitoring of clinical trials. |
CTTI’s DMC recommendations | While not specific to ePCTs, the recommendations address the role of the DMC, DMC composition, communication among DMC members and other stakeholders, the DMC charter, and issues related to DMC training. |
Ethical and Regulatory Issues in Pragmatic Clinical Trials: Special Issue of Clinical Trials | This page provides background and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in the special issue of Clinical Trials describes an issue in detail (e.g., privacy, informed consent) and, where possible, attempts to provide guidance for future pragmatic clinical trials. |
SECTIONS
CHAPTER SECTIONS
sections
- Introduction
- Which PCTs Should Have a DMC?
- Monitoring Protocol Adherence
- Data Issues With Monitoring PCTs
- Monitoring for Serious Adverse Events
- Futility Assessment
- Case Study: Planning for Monitoring PCTs
- Including Stakeholder Perspectives
- Special Training and Resources for DMCs of Pragmatic Trials
- Additional Resources
- Futility Assessment – ARCHIVED
current section : Additional Resources
- Introduction
- Which PCTs Should Have a DMC?
- Monitoring Protocol Adherence
- Data Issues With Monitoring PCTs
- Monitoring for Serious Adverse Events
- Futility Assessment
- Case Study: Planning for Monitoring PCTs
- Including Stakeholder Perspectives
- Special Training and Resources for DMCs of Pragmatic Trials
- Additional Resources
- Futility Assessment – ARCHIVED